Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients
This trial is active, not recruiting.
|Condition||asian colorectal cancer patients|
|Phase||phase 2/phase 3|
|Sponsor||National University Hospital, Singapore|
|Start date||January 2011|
|End date||August 2013|
|Trial identifier||NCT01189903, CR01/18/10|
1. Primary Endpoints
- Biomarker data suggestive of regorafenib-mediated inhibition of the RAS-RAF- MEK-ERK signal transduction pathway,of various tyrosine kinase receptors and/or of angiogenesis.
- Evaluation of potential relationships between biomarker data and clinical activity.
- Evaluation of a novel biomarker technology (Prometheus COPIA platform)
2. Secondary Endpoints
- Biomarker data suggestive of regorafenib-mediated effects on circulating rare cells.
- Comparison of tumor genetic profiles obtained using DNA isolated from plasma, tumor biopsies and circulating tumor cells.
- Patient safety data
- Pharmacokinetics of regorafenib
- Changes in tumor metabolic activity as measured by PET CT scan (optional)
Male or female participants at least 21 years old.
- Histologically or cytologically proven metastatic colorectal adenocarcinoma that is refractory to standard therapy and not amenable to surgery with curative intent.
- Tumor characteristics:
- At least one lesion that is suitable for a repeated biopsy; eg. subcutaneous nodule, skin lesion, rectal tumor, colonic mass easily reached by colonoscopy, peritoneal masses at least 3cm in maximum diameter that are easily assessable by image guided core biopsy.
- For liver lesions, more superficially located lesions at least 3cm in maximum dimension with a rim of normal liver tissue, assessable safely by image guided core biopsy as determined by an experienced interventional radiologist.
- Eastern Cooperative Oncology Group ECOG performance status of 0 or 1 (see Appendix 10.4).
- Adequate bone marrow function (absolute neutrophil count =1,500/mm3; platelet count =100000/mm3; hemoglobin =9g/dl
- Adequate liver and renal function as assessed by the following laboratory requirements conducted within 7 days of starting to study treatment:
- Total bilirubin < 1.5 x the upper limit of normal (ULN).
- Alanine transaminase (ALT) and aspartate aminotransferase (AST) < 2.5 x ULN (< 5 x ULN for patients with liver involvement of their cancer).
- Amylase and lipase < 1.5 x the ULN
- Serum creatinine < 1.5 x the ULN.
- Glomerular filtration rate (GFR) = 30 ml/min/1.73 m2 according to the MDRD (Modified diet in renal disease) abbreviated formula
- Prothrombin time, international normalized ratio (INR) and partial thromboplastin time less than or equal to 1.2 times the ULN.
- Male or female at least 21 years of age.
- A female subject is eligible to enter and participate in the study if she is:
- Non-childbearing potential (ie. physiologically incapable of becoming pregnant) including any women who:
- Has had a hysterectomy or
- Has bilateral oophorectomy (ovariectomy) or
- Has bilateral tubal ligation or
- Is postmenopausal (demonstrate total cessation of menses for greater than or
- Childbearing potential, has a negative serum or urine pregnancy test at screening, agrees to one of the following: double barrier contraception or abstinence.
- Predicted life expectancy of at least 12 weeks.
- Resting oxygen saturation greater than 92% on room air.
- Written informed consent.
- Able to swallow and retain oral medication.
- Prothrombin time (PT), International Normalized Ratio for PT (PT INR), and partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) within normal limits.
|Official title||Clinical Evaluation - A Phase IIA Proof of Concept Study of Regorafenib (Bayer 73-4506) in Biopsy-amenable Asian Colorectal Cancer Patients|
|Principal investigator||Boon Cher Goh, MBBS, MRCP|
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